What is Regulatory Compliance?

Regulatory compliance means that your medical device or IVD meets all applicable legal requirements – from development and approval to the entire product lifecycle. It ensures patient safety and product quality at all times. With Metecon at your side, you achieve compliance efficiently, practically, and future-proof.

How does digitalization support your regulatory affairs processes?

Digitalization creates transparency, efficiency, and speed in regulatory workflows. Automated processes simplify document management, reduce errors, and accelerate approvals. With Metecon, you digitalize regulatory affairs in a way that sustainably relieves your team.

Why is post-market surveillance crucial for market success?

Post-Market Surveillance (PMS) is the continuous monitoring of your products after they have been placed on the market. It provides essential data on safety, performance, and risks, enabling you to take corrective actions at an early stage. A strong PMS system not only protects patients but also ensures long-term market access and strengthens trust in your products.

How does Metecon support market access in Europe and worldwide?

Metecon supports you from strategy to implementation: We create technical documentations, develop approval strategies, and, if required, take on roles such as PRRC and EC-/CH-REP. With our expertise in the international regulatory environment, we pave the way for your access to new markets – safely, efficiently, and with maximum relief for your team.

Your regulatory compliance partner

in Medical and In Vitro Diagnostic Devices

Documentation and market access

Verification and validation

Market access for medical devices and IVDs - efficient, safe, successful

How can you achieve regulatory compliance for your medical device – efficiently and safely?

Regulatory compliance for medical devices means meeting MDR requirements and country-specific regulations. This is complex, from development and approval to post-market surveillance. With a clear strategy, you secure market access and sustainable success.

Your key compliance building blocks for your medical device:

Metecon provides you with 360° services across the entire lifecycle of your medical device.

Your medical device can only be successfully and legally marketed if you, as the manufacturer, comply with the regulatory requirements of the target market. These requirements, set by the MDR (Medical Device Regulation, EU regulation for medical devices) and other country-specific rules, are diverse and complex. We help you fulfill them all – efficiently, pragmatically, and with tailored solutions.

Our 360° service for your medical device

How do you ensure market access and post-market surveillance for your IVD – reliably and in compliance?

IVDs are regulated under the IVDR and additional national requirements. From development to performance evaluation and post-market surveillance, manufacturers must demonstrate compliance throughout the lifecycle. With the right strategy, you ensure both market access and product safety.

Your key IVD compliance building blocks:

Metecon supports you on all levels and at every stage of the IVD lifecycle.

In vitro diagnostics (IVDs) are medical devices regulated under a specific regulation – the IVDR (In Vitro Diagnostic Regulation, Regulation (EU) 2017/746). The efficient interaction of quality management processes must ensure safe and reliable products that are maintained throughout the product lifecycle. Metecon advises and supports you comprehensively and with practical solutions.

Our services for your IVD

More than 25 years of experience in regulatory compliance

Metecon GmbH is one of the pioneers in Germany when it comes to standard- and guideline-compliant consulting and support for medical device manufacturers and manufacturers of IVDs: Since 1999, we have been a strategic partner for our customers in the creation and maintenance of product files for medical devices and IVDs, in the verification and validation of these products, for all aspects in the areas of clinical affairs and regulatory affairs, and in the optimization of quality management processes.

Our services for medical devices

Our services for IVDs

What do our clients say about working with Metecon?

From initial projects to long-term partnerships: Our clients especially value reliability and tailored solutions.

Whether start-ups, SMEs, or large corporations: We put together project teams according to our clients' needs; due to the size of our company, we can draw from a wide range of resources: no matter what expertise you need, we are ideally positioned.

For us, there is no such thing as "too small" or "too big" - we see manufacturers of medical devices and IVDs that we can help to enter the market and maintain existing certificates with our know-how and experience.

All the nicer when a business relationship grows into a real partnership. We thank our customers for their kind words and are very happy to work with them and other great people on exciting projects.

With our experience and expertise, we support you reliably from concept to market success. Let’s talk about your project!

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Why regulatory compliance with Metecon?

Our team is reliable partner when it comes to documentation, verification, validation, market access, and market surveillance (PMS, PMCF/PMPF) of your medical device or IVD. Capacity bottlenecks are passé with Metecon; we support you sometimes selectively, sometimes over a longer distance, but always reliably and solution-oriented. We are growing continuously so that we can serve your request flexibly and quickly.

Our more than 60 experts in the respective fields are all engineers and scientists. This allows us to quickly provide you with the best support for any size of the project and any topic so that you can meet the regulatory requirements of the market.

Get to know us – no strings attached. We look forward to meeting you!